Maybe an unpopular opinion, but...
If your press release claims a trial succeeded, you should *at a bare minimum* disclose effect size and stats for primary endpoint.
If a puny biotech had issued a data-free PR like this, @adamfeuerstein would've ripped them a new one.
$CRVS Updated Results of Phase 1b Clinical Trial
Key takeaways for Cohort 4:
- 8 week treatment (n=12) shows substantial reduction in EASI (-72%)
- 75% of patients achieved EASI 75 vs 20% for pbo
- 33% of patients achieved IGA 0 or 1 vs 0% for pbo, note that Corvus has not released the baseline IGA for cohort 4
- 50% of cohort 4 patients failed prior system therapy
- No new safety signals were reported, no significant reports of infections (potential class effect for T-cell modulation)
Current Market Cap:
CRVS - $900M
$KYMR - $5 500M (Lead asset in phase 2 trial for AD)
Will be posting a valuation analysis for CRVS in the coming days...
Dave Ricks has been at @EliLillyandCo for 20% of its 150-year history. He came to the pub, poured his own Guinness, and gave us a 2-hour state of the pharma union: drug prices, clinical trials, patent clocks, the rise of generics, Chinese peptides, compounding pharmacies, the US healthcare system, and how the broad success of GLP-1s have transformed Lilly's business. If you've never heard Dave speak before, you're in for a treat.
Timestamps:
00:00 Intro
05:08 Making R&D decisions
10:11 Clinical trials
24:59 Drug pricing
32:43 Stimulating more R&D
45:16 Pros and cons of US healthcare
58:20 New pharma business models
01:05:53 Stripe + enterprises
01:07:00 China
01:16:31 Generics
01:22:37 GLP-1s
1:37:43 r/Peptides
01:41:25 LillyDirect
01:46:35 Why do investors love LLY?
You often see people say that a SMid with multiple pipeline candidates is less risky and that's just not strictly correct. You are paying for that perceived less risk in other ways
Good point. Although I do find Soquelitinib’s placebo response at day 28 a bit odd (flat for two weeks), given than their baselines are low. But since it’s a phase 1, small cohort size could account for that. Just hope to continue to see that separation in larger n trials.
I do like the MOA of Soquelitinib, the drug has a lot of potential and currently undervalued. Looking forward to the cohort 4 data.
Agreed EASI reductions are not meaningful due to high placebo response (their baseline EASI was ~23). However, they did achieve stat-sig in IGA for all doses, which is the recommended FDA primary endpoint. Plus they also saw stat-sig (and rapid) itch reduction.
The drug also seems pretty safe, is a BID pill, and got a Fast-track designation by the FDA. Just curious as to how that plays into your modelling of $CRVS's ITKi market share given its in phase 3?
Idk I think there’s a market opportunity for a once monthly GLP1 if the safety profile holds up. With 173 m obese patients, any dosing/ROA edge could capture market share.
However, the real value lies in a once monthly GLP-1 + Amylin. To my knowledge there’s no other asset in development with that profile in ph 1/2.
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Great point. It's hard to say as they haven't published the full ph 2 data set though. They were either overconfident in their ph 2 results (with Q4W dosing) and thought Q2W for 8 weeks would hit a home run.. or they were trying to minimize the candiasis events or other AEs they were concerned with. Ex: UCB saw some suicide ideation events in their ph 3 trial.
@financebully Thanks! It's in their MIRA presentation. I didn't expect one arm trial to fail.. should have considered a scenario for that. In hindsight, the BMKZ drop from phase 2 -> 3 was the biggest signal that a <20% outcome was more likely.